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"Psychosocial Intervention - methods"
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Effectiveness of Psychological Capital Intervention and Its Influence on Work-Related Attitudes: Daily Online Self-Learning Method and Randomized Controlled Trial Design
2020
Research on positive psychology intervention is in its infancy; only a few empirical studies have proved the effectiveness and benefits of psychological capital interventions in workplaces. From a practical perspective, a more convenient intervention approach is needed for when organizations have difficulties in finding qualified trainers. This study aims to extend the psychological capital intervention (PCI) model and examine its influence on work-related attitudes. A daily online self-learning approach and a randomized controlled trial design are utilized. A final sample of 104 full-time employees, recruited online, is randomly divided into three groups to fill in self-report questionnaires immediately before (T1), immediately after (T2), and one week after (T3) the intervention. The results indicate that the intervention is effective at improving psychological capital (PsyCap), increasing job satisfaction, and reducing turnover intention. The practical implications for human resource managers conducting a flexible and low-cost PsyCap intervention in organizations are discussed. Limitations related to sample characteristics, short duration effect, small sample size, and small effect size are also emphasized. Due to these non-negligible drawbacks of the study design, this study should only be considered as a pilot study of daily online self-learning PsyCap intervention research.
Journal Article
Feasibility, acceptability, and preliminary efficacy of a self-directed online psychosocial intervention for women with metastatic breast cancer: Finding My Way-Advanced
2024
Purpose
Few digital interventions target patients with advanced cancer. Hence, we feasibility-tested
Finding My Way-Advanced (FMW-A)
, a self-guided program for women with metastatic breast cancer.
Methods
A single-site randomised controlled pilot trial was conducted. Participants were recruited through clinicians, professional networks, and social media and randomised to intervention or usual-care control. Participants were randomly allocated to either the intervention (
FMW-A;
a 6-week, 6-module CBT-based online self-directed psychosocial program for women with MBC + usual care resources) or control (usual care resources: BCNA’s Hope and Hurdles kit). Feasibility outcomes included rates of recruitment, uptake, engagement, and attrition. Distress, QOL, and unmet needs were evaluated for signals of efficacy, and qualitative feedback was collected to assess acceptability.
Results
Due to COVID-19 and funding constraints, the target recruitment of 40 was not reached (
n
= 60 approached;
n
= 55 eligible;
n
= 35 consented). Uptake was high (
n
= 35/55; 63.6%), engagement modest (median 3/6 modules per user), and attrition acceptable (66% completed post-treatment). Efficacy signals were mixed: compared to controls,
FMW-A
participants experienced small improvements in fear of progression (
d
= 0.21) and global QOL (
d
= 0.22) and demonstrated a trend towards improvements in cancer-specific distress (
d
=
0.13
) and role functioning (
d
= 0.18). However,
FMW-A
participants experienced small-to-moderate deteriorations in general distress (
d
= 0.23), mental QOL (
d
= 0.51), and social functioning (
d
= 0.27), whereas controls improved. Qualitatively, participants
(n
=
4)
were satisfied with the program, perceived it as appropriate, but noted some sections could evoke transient distress.
Conclusion
The study demonstrated feasibility (high uptake and acceptable retention) and generated realistic recruitment estimates. While
FMW-A
appears promising for targeting cancer-specific distress and fear of progression, the mixed findings in quality of life and general distress warrant further revisions and testing.
Journal Article
Smart wearable devices as a psychological intervention for healthy lifestyle and quality of life
2021
Purpose
Creating a healthy lifestyle is important across different life stages. Commercial smart wearable devices are an innovative and interesting approach as an early psychological intervention for modifying health-related behaviors. Therefore, the purpose of this study was to explore the effects of smart wearable devices on health-promoting lifestyles and quality of life.
Methods
The study design was a three-parallel randomized controlled trial with a 3-month intervention. Two commercial smart wearable devices (smartwatches and smart bracelets) with different levels of complicated functions were applied as a psychological intervention in comparison with a smartphone app as the control group. Participants were healthy young adults with a median age of 26 years. Outcome measurements were conducted by self-administered questionnaires. Chi-square tests and ANOVA were performed for testing the difference of participants at baseline, and generalized estimating equations were performed for testing the effect of the intervention.
Results
At the beginning, 81 participants were recruited and 73 participants completed the study. Results of a healthy lifestyle demonstrated significant group effects of exercise and a significant effect of the interaction for self-actualization and stress management in the experimental group with a smartwatch (Self-actualization: MD = 0.35[− 0.10,0.80]; Exercise: MD = 0.21[− 0.33 0.75]; Stress management: MD = 0.36[− 0.04,0.76]) by comparing with only using mobile app (Self-actualization: MD = − 0.03[− 0.25,0.18]; Exercise: MD = − 0.12[− 0.38,0.14]; Stress management, MD = − 0.28[− 0.55,0.00]). The significant effect of group-by-time interaction for self-actualization was found in the experimental group with a smart bracelet (MD = 0.05[− 0.30,0.20]) by comparing with the control group. The GEE-adjusted model indicated significant effects of the interaction on the comprehensive, physical, and mental quality of life in the experimental group with the smartwatch (Comprehensive: MD = 0.24[− 0.04,0.52]; Physical: MD = 0.67[0.26,1.09]; Mental: MD = 0.72[0.29,1.16]) by comparing with the control group (Comprehensive: MD = − 1.57[− 2.55, − 0.59]; Physical: MD = 0.25[0.00,0.50]; Mental: MD = 0.08[− 0.11,0.27]).
Conclusion
From a psychological perspective, smart wearable devices have potential benefits of shaping a healthy lifestyle and improving the quality of life. Enhancing the utility of commercial well-designed smart wearable devices is an innovative and effective strategy for promoting public health.
Journal Article
Longitudinal Follow-Up Study of Social Intervention Outcomes for Children on the Autism Spectrum
by
Lodi-Smith, Jennifer
,
Lopata, Christopher
,
Donnelly, James P
in
Acknowledgment
,
Adolescent
,
Autism
2025
A prior randomized trial found a school social intervention yielded significantly better outcomes (social and autism features) immediately following intervention compared to typical school programming (services-as-usual [SAU]) for children on the autism spectrum. In that study, children in the SAU condition subsequently completed a summer social intervention. This study tested longer-term maintenance of effects for children who completed both interventions. A total of 103 children (ages 6–12 years) on the autism spectrum enrolled and 102 completed the initial RCT. Following the summer social intervention, 90 children from the original RCT completed the longer-term follow-up study. In addition to baseline and posttest in the initial RCT, children from both groups were tested at three follow-up points (five total testing points). At the time of first longitudinal follow-up testing, the children were 1.25–4.25 years post-intervention (ages 8–15 years). Longitudinal multilevel model analyses (and follow-up contrasts) revealed significant improvements for both groups post-intervention on measures of emotion recognition, autism features, and social skills, indicating maintenance of post-intervention improvements over the three follow-up testing points. No between-group differences were found for autism features or social skills over time; however, the school social intervention may have yielded somewhat better emotion recognition skills. Exploratory tests found that child IQ, language level, and length of time since completing the intervention did not moderate outcomes. Both social interventions yielded positive and durable longer-term improvements for children on the autism spectrum. [ClinicalTrials.gov, NCT03338530; November 8, 2017; original retrospectively registered trial]
Journal Article
A Pilot Randomised Control Trial Exploring the Feasibility and Acceptability of Delivering a Personalised Modular Psychological Intervention for Anxiety Experienced by Autistic Adults: Personalised Anxiety Treatment-Autism (PAT-A)
2024
Anxiety is commonly experienced by autistic people and impacts on quality of life and social participation. New anxiety interventions are required to effectively meet the needs of autistic people. Personalised Anxiety Treatment-Autism (PAT-A©) is a bespoke, modular approach to treating anxiety in up to 12 sessions. This study explored the feasibility and acceptability of delivering PAT-A© in the UK National Health Service (NHS). A single-blind randomised controlled trial design. Thirty-four autistic adults were recruited via clinical services and randomised to receive either PAT-A© or enhanced treatment as usual (CCSP). Outcome assessments relating to anxiety, quality of life and related constructs were completed at baseline, immediately post intervention; and at 3 and 12 months. Seventy-one percent of the PAT-A© group and 65% of the CCSP met diagnostic threshold for at least three anxiety disorders. Retention was good across both groups, with 82% (N = 14/17) completing the full course of PAT-A© and 71% (N = 12/17) attending both psychoeducational sessions in CCSP. 94% in PAT-A© and 82% in CCSP completed some follow up assessment 3 months post-intervention. Thematic analysis of interview data revealed that many participants valued the personalised approach, developed transferable skills and experienced positive changes to their anxiety. Participants were willing to be recruited and randomised, PAT-A© was feasible to deliver in the NHS and the trial methods and materials were acceptable. Our findings indicate that a fully powered clinical and cost-effectiveness trial of PAT-A© is warranted.
Journal Article
Protocol for a Hybrid-type 1 pilot study of a randomized control trial of a brief, peer-delivered treatment to improve father depression and child mental health in Kenya
2025
Few treatments specifically target father depression and alcohol use, despite their high prevalence worldwide and adverse impacts on families and youth. Fathers are also less likely to engage in treatment than female caregivers. To address this gap, a team of US- and Kenyan-based clinician-researchers developed Learn, Engage, Act, Dedicate (LEAD), a five-session, task-shifted psychosocial intervention for fathers in Eldoret, Kenya.
This hybrid type-1 study aims to evaluate the feasibility, acceptability, and preliminary effectiveness of LEAD, a peer-father delivered psychosocial intervention for fathers at risk for depression and alcohol use. Secondary aims include exploring changes in child mental health and family functioning, potential mechanisms of change, and key implementation outcomes such as fidelity.
We will conduct a hybrid type-1 pilot study using a parallel randomized controlled trial (RCT) design, enrolling 102 fathers randomized 2:1 to LEAD or a waitlist control group. All participants will be offered treatment as usual at baseline, with waitlist participants receiving LEAD following the waitlist period. Assessments will be conducted with fathers, their female partners, and one child aged 8-17. Primary aims are to explore changes in fathers' depression and alcohol use; secondary aims include examining changes in family functioning and child well-being, understanding mechanisms driving change or nonresponse, and assessing the feasibility and acceptability of peer-father counselor implementation.
Findings will inform a future hypothesis-testing hybrid trial to examine LEAD's effectiveness in improving father and child mental health and evaluate associated implementation strategies. This work will contribute to strategies for engaging and retaining men in mental health services. Trial Registration #: NCT06489314 (ClinicalTrials.gov); July 4, 2024.
Journal Article
Effectiveness of a peer-facilitated, recovery-focused self-illness management program for adults with first-episode psychosis: A randomized controlled trial
2025
BackgroundPsychosocial interventions for people with mental illness are increasingly focusing on facilitating recovery and self-care. Despite evidence from Europe on the short-term effects of recovery self-planning programs for people discharged from crisis resolution teams, similar programs and supporting evidence in other countries or healthcare contexts are lacking, particularly regarding cultural adaptation and long-term assessment. This randomized controlled trial compared a 4-month peer-facilitated, recovery-focused self-illness management (Peer-RESIM) program for Chinese adults with first-episode psychosis with psychoeducation (PE) and treatment as usual (TAU).MethodsPatients (N = 198) were recruited from four Integrated Community Centres for Mental Wellness in Hong Kong and randomly assigned to the Peer-RESIM, PE, or TAU group (66/group). The primary outcomes were recovery and functioning levels; the secondary outcomes were psychotic symptoms, problem-solving ability, rehospitalization rate, and service satisfaction. Assessments were conducted at baseline and immediate, 9, and 18 months postintervention.ResultsThe generalized estimating equation test revealed that the Peer-RESIM group reported significantly greater improvements in recovery, functioning, problem-solving ability, psychotic symptoms, average duration of rehospitalizations, and service satisfaction (p = 0.01–0.04, small to large effect sizes) than the TAU group at all three posttests and the PE group at 18 months postintervention.ConclusionsThe Peer-RESIM can enhance long-term recovery and self-care in adults with early-stage psychosis.
Journal Article
Efficacy of a brief psychological intervention for adolescents with recent suicide attempt: A randomized clinical trial
by
Pedrola-Pons, Anna
,
Sáiz, Pilar A
,
Díaz-Marsá, Marina
in
Addictive behaviors
,
Anxiety disorders
,
Clinical trials
2025
BackgroundAdolescents are at a heightened risk of suicide reattempts following hospital discharge, but few evidence-based interventions exist. This study evaluated the efficacy of the self-awareness of mental health (SAM) program combined with treatment as usual (TAU) versus TAU alone in reducing reattempts among high-risk adolescents.MethodsA randomized clinical trial was conducted across nine Spanish hospitals (January 2021–March 2024) with 261 adolescents (12–17 years) who had attempted suicide within the last 15 days. Participants were assigned to SAM + TAU (n=128) or TAU (n=133), with 12-month follow-up. The primary outcome was suicide reattempts within 12 months; secondary analyses examined time to reattempt and associated risk factors.ResultsAfter 12-months, no significant differences were found in reattempt rates [22.6% (SAM) versus 27.8% (TAU); OR=0.610, 95%CI (0.321–1.151), p=0.127] or time to reattempt [HR=0.606, 95%CI (0.390–1.021), p=0.060]. In SAM, attentional impulsivity emerged as a significant risk factor [HR=1.126, 95% CI (1.004–1.263), p=0.043], while nonplanning impulsivity was protective [HR=0.878, 95%CI (0.814–0.948), p<0.001]. In TAU, increased suicide risk was linked to suicidal intentionality [HR=1.341, 95%CI (1.009–1.782), p=0.044] and more prior attempts [HR=1.230, 95%CI (1.039–1.457), p=0.016]. Conversely, fewer psychiatric diagnoses emerged as a protective factor [HR=0.821, 95%CI (0.677–0.996), p=0.045].ConclusionsWhile no significant differences were found between groups, SAM identified important psychological factors influencing suicide risk. These findings provide a foundation for targeted interventions to prevent reattempts in adolescents.
Journal Article
A Suicide Attempt Multicomponent Intervention Treatment (SAMIT Program): study protocol for a multicentric randomised controlled trial
2024
Background
Suicide has become a first-order public health concern, especially following the negative impact of COVID-19 on the mental health of the general population. Few studies have analysed the effects of early psychotherapeutic interventions on subjects who have attempted suicide, and even fewer have focused on those hospitalized in non-psychiatric units after a Medically Serious Suicide Attempt (MSSA). The main aim of this study is to describe the protocol designed to evaluate the effectiveness of individual psychological treatment for patients hospitalized after an MSSA. The secondary objectives of the study are: (1) to evaluate the impact on quality of life and other psychosocial variables of patients with a recent MSSA who receive early psychological intervention; (2) to analyse the biological, psychological, and clinical impact of early psychotherapeutic treatment on subjects hospitalized after an MSSA.
Methods
A longitudinal randomised controlled trial will be conducted with patients over 16 years of age admitted to two general hospitals. The case intervention group will enrol for 8-sessions of individual psychotherapy, Suicide Attempts Multi-component Intervention Treatment (SAMIT), combining Dialectical Behaviour Therapy (DBT), Mentalization-Based Therapy (MBT), and Narrative approaches, while the control group will receive a treatment-as-usual intervention (TAU). Longitudinal assessment will be conducted at baseline (before treatment), post-treatment, and 3, 6, and 12 months after. The main outcome variable will be re-attempting suicide during follow-up.
Discussion
Some psychotherapeutic interventions, usually implemented in outpatient, have proven to be effective in preventing suicidal behaviours. The combination of some of these may be a powerful treatment for preventing future SA in patients hospitalised after an MSSA, which is the most severely suicidal subgroup. Moreover, assessment of the biological, clinical and psychometric impact of this new intervention on patients during the first year after the attempt may help understand some of the multi-level factors associated with the effectiveness of psychotherapeutic interventions in MSSAs. The prevalence of high suicide rates requires the design of effective psychological interventions for their prevention, and also in order to design new pharmacological and psychological treatments.
Trial registration
ClinicalTrials.gov ID: NCT06238414. Date of registration: 1st February 2024, final update is protocol version 3.0, 19th March 2024.
Journal Article
Developing a brief motivational intervention for young adults admitted with alcohol intoxication in the emergency department – Results from an iterative qualitative design
by
Gaume, Jacques
,
Fortini, Cristiana
,
Daeppen, Jean-Bernard
in
Addictions
,
Adolescent
,
Adolescents
2021
Unhealthy alcohol use among young adults is a major public health concern. Brief motivational interventions for young adults in the Emergency Department (ED) have shown promising but inconsistent results.
Based on the literature on brief intervention and motivational interviewing efficacy and active ingredients, we developed a new motivational intervention model for young adults admitted in the ED with alcohol intoxication. Using an iterative qualitative design, we first pre-tested this model by conducting 4 experimental sessions and 8 related semi-structured interviews to evaluate clinicians' and patients' perceptions of the intervention's acceptability and feasibility. We then conducted a consultation meeting with 9 international experts using a nominal group technique. The intervention model was adjusted and finally re-tested by conducting 6 new experimental sessions and 12 related semi-structured interviews. At each round, data collected were analyzed and discussed, and the intervention model updated accordingly.
Based on the literature, we found 6 axes for developing a new model: High level of relational factors (e.g. empathy, alliance, avoidance of confrontation); Personalized feedback; Enhance discrepancy; Evoke change talk while softening sustain talk, strengthen ability and commitment to change; Completion of a change plan; Devote more time: longer sessions and follow-up options (face-to-face, telephone, or electronic boosters; referral to treatment). A qualitative analysis of the semi-structured interviews gave important insights regarding acceptability and feasibility of the model. Adjustments were made around which information to provide and how, as well as on how to deepen discussion about change with patients having low levels of self-exploration. The experts' consultation addressed numerous points, such as information and advice giving, and booster interventions.
This iterative, multi-component design resulted in the development of an intervention model embedded in recent research findings and theory advances, as well as feasible in a complex environment. The next step is a randomized controlled trial testing the efficacy of this model.
Journal Article